EMMC investigation contributes to recall, earns hospital FDA award

BANGOR, Maine — It’s not often that the U.S. Food and Drug Administration calls out a hospital for its contribution to the promotion of patient safety, but it happened to Eastern Maine Medical Center and EMMC Risk Management coordinator Cheryl Long, RN, LNCC, CPHRM.

The FDA awarded the hospital its Certificate of Outstanding Contribution in Promoting Patient Safety with Medical Devices in September 2013.

Cheryl Long investigated the Cordis Optease Vena Cava Filter after Daniel O’Brien, MD, diagnostic radiologist, Spectrum Medical Group, alerted EMMC’s Risk Management to a potential issue. This medical device is inserted into a vein that returns blood to the heart from the legs. It catches blood clots so they do not move through the body and prevents a recurrent pulmonary embolism — a life-threatening condition.

After discovering a problem with the implantation of the device, Long submitted a voluntary report to the FDA detailing the investigation carried out at EMMC, which included photographs of the product labeling. The FDA was then able to determine that the device had been mislabeled by the manufacturer and responded by issuing a Class 1 Recall, which removed the product from hospitals in the United States, Canada, and Panama.

No EMMC patients were injured due to this medical device issue.

“We are always on the lookout for medical devices that don’t work properly. It’s important to get them flagged early before any patient has an adverse event,” said Long, in an EMMC press release. “It’s part of our commitment to patient safety, and we’re doing it every day.”

Other EMMC healthcare professionals who participated in identifying the issue with the Vena Cava Filter were: David Burke, MD, FACS, Surgery and Trauma Specialist of Maine; James Clarke, MD, FACS, Northeast Surgery of Maine; Mark Grant, MD, Surgery and Trauma Specialists of Maine; and David Ahola, MD, Chief of Radiology.